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Abstract:

A syringe device includes a syringe barrel and piston having a fluid
passageway extending from a vial port. Another syringe device includes a
syringe barrel, a piston sleeve and an insert. A channel extends along a
side of the insert. A valve controls fluid communication between the
channel and the syringe barrel. Another syringe device has a syringe
barrel, a piston sleeve and an insert. A valve controls fluid
communication between a compartment within the insert and the syringe
barrel. A method of preparing a medication includes providing a component
within a syringe barrel and another component within a compartment of a
piston insert. A seal is over-molded onto a tip of the insert and an end
of a piston sleeve. The sleeve is rotated relative to the insert to
establish fluid communication between the compartment and the barrel
chamber.

Claims:

1. A syringe device comprising: a syringe barrel; a piston sleeve; a
sleeve insert having a first end insertable within the sleeve, an
opposing second end, and a length defined by the distance between the
first and second ends; a fluid channel extending along an exterior side
of the sleeve insert from the first end at least a portion of the length
of the sleeve insert; and a rotary valve controlling fluid communication
between the fluid channel and the syringe barrel.

2. The syringe device of claim 1 wherein the rotary valve is configured
to establish fluid communication between the syringe barrel and the fluid
channel by rotation of the sleeve insert relative to the piston sleeve.

3. The syringe device of claim 1 further comprising a vial housing
associated with the second end of the sleeve insert.

5. A syringe device comprising: a syringe barrel; a piston sleeve; a
sleeve insert having a first end insertable within the sleeve, an
opposing second end, and a length defined by the distance between the
first and second ends; a compartment disposed within the sleeve insert;
and a valve controlling fluid communication between the compartment and
the syringe barrel.

6. The syringe device of claim 5 wherein the valve is configured to
establish fluid communication between the syringe barrel and the
compartment by rotation of the sleeve insert relative to the piston
sleeve.

8. The syringe device of claim 5 wherein the sleeve insert comprises a
tip portion and a body portion, and further comprising a seal over-molded
onto the tip potion and onto the piston sleeve.

9. The syringe device of claim 8 wherein the body portion irreversibly
attaches to the tip portion of the sleeve insert.

10. A method of preparing a medication agent for administration to an
individual, comprising: providing a syringe comprising a syringe barrel
and a piston disposed at an initial position relative to the syringe
barrel, the piston comprising a piston sleeve and a sleeve insert;
providing a first component within the syringe barrel; providing a second
component within a vial; providing a valve associated with a fluid
passageway between the vial and the syringe barrel, the valve being
initially provided in a closed position, blocking fluid passage through
the passageway; repositioning the valve; sliding the piston to join the
first component with the second component; mixing the first and second
component to form a medication agent; and drawing the medication agent
into the syringe barrel.

11. The method of claim 10 wherein the valve is a rotary valve actuated
by rotation of the piston sleeve relative to the sleeve insert.

12. The method of claim 10 wherein the fluid passageway comprises a
channel disposed along a sidewall surface of the sleeve insert.

13. The method of claim 10 wherein the piston further comprises a seal
over-molded onto the piston sleeve, the seal having an opening alignable
with the channel by rotation of the sleeve insert relative to the piston
sleeve.

14. The method of claim 10 further comprising: providing a piercing
structure associated with the piston insert; and prior to repositioning
the valve, utilizing the piercing structure to pierce a septum comprised
by the vial.

Description:

RELATED PATENT DATA

[0001] This application is a continuation of U.S. patent application Ser.
No. 11/558,146 which was filed Nov. 9, 2006, which claims priority under
35 U.S.C. §119 to U.S. Provisional Application No. 60/735,481, which
was filed Nov. 9, 2005; and claims priority to U.S. Provisional
Application No. 60/763,647, which was filed Jan. 30, 2006, the entirety
of each of which are incorporated herein by reference.

[0003] Preparation of medicants or medication agents and administration of
such agents to an individual often involves mixing of two or more
components to form the agent and subsequent delivery of the mixed
medicant to the individual. The mixing of components can typically
involve extraction of one component in fluid form from a vial or other
container and transfer of such components into a separate container which
holds another component. In particular instances, only a portion of the
contents of a vial or container is to be utilized for preparing a mixture
prior to administering. Accordingly, the extraction and transfer can
involve precise measuring of one or more components to be mixed.

[0004] A variety of problems may occur when utilizing conventional
methodology and devices for mixing and/or administering medicants to an
individual. For example, where multiple components are to be mixed,
extraction and transfer of one component and introduction of such
component into another component can potentially expose one or both of
the components to a non-sterile or contaminated environment leading to
contamination of the resulting medicant. Additionally, incomplete
extraction or improper measurement of one or more components can result
in preparation and/or administration of an improper dosage. In particular
instances, once a medicant is mixed the mixture must again be extracted
from a vial or container into a syringe prior to administering to an
individual. Such additional transfer can lead to additional opportunities
for contamination, incomplete extraction of contents and/or inaccurate
measuring of a component or the resulting medicant.

[0005] In practice, there is limited availability of sterile environments
for maintaining sterility during transfer and/or mixing of components, or
preparation and transfer of medicants. Additional errors can result from
use of the wrong diluent to reconstitute the medication. Finally,
preparation of medicants utilizing multiple components can be tedious and
time consuming due to factors such as the need to access individually
packaged items such as separate vials and/or transfer devices, or to
measure one or more components to be combined to form the medicant.

[0006] It would be desirable to develop alternative methodology and
systems for preparation and administration of medicants.

SUMMARY OF THE INVENTION

[0007] In one aspect the invention encompasses a syringe device. The
device includes a syringe barrel and piston having a first end insertable
within the syringe barrel. A second end of the piston opposes the first
end and the piston has an overall length defined between the first and
second ends. A vial port is disposed within the piston and is configured
to receive a vial in lengthwise orientation along a portion of the
overall length of the piston. A fluid passageway extends through the
piston from the vial port through the first end of the piston.

[0008] In one aspect the invention encompasses a syringe piston having a
stem portion which includes one or more projections. A sealed portion is
over-molded onto the stem portion and covers the one or more projections.

[0009] In another aspect the invention encompasses a syringe device having
a syringe barrel and a syringe piston having a first end insertable
within the syringe barrel and a second end opposing the first end. A vial
housing is associated with and extends from the second end of the piston.
A piercing structure is associated with the second end of the piston and
extends into the vial housing.

[0010] In one aspect the invention encompasses a syringe device including
a syringe barrel, a piston sleeve and a sleeve insert. The sleeve insert
has a first end insertable within the sleeve and an opposing second end.
The sleeve insert has a length defined by the distance between the first
and second ends. A fluid channel extends along an exterior side of the
sleeve insert from the first end at least a portion of the length of the
sleeve insert. A rotary valve controls fluid communication between the
fluid channel and the syringe barrel.

[0011] In one aspect the invention encompasses a syringe device having a
syringe barrel and a piston sleeve with a sleeve insert having a first
end insertable within the sleeve and an opposing second end with a length
of the sleeve insert being defined by the distance between the first and
second ends. A compartment is disposed within the sleeve insert and a
valve controls fluid communication between the compartment and the
syringe barrel.

[0012] In another aspect the invention encompasses a medication agent
preparation system. The system includes a syringe having a syringe barrel
with an internal chamber, a piston having a first end, a second end and a
fluid passageway passing longitudinally through the piston, at least a
portion of the piston including the first end being inserted within the
chamber. A valve is associated with the fluid passageway and includes a
valve body and a cap over-molded onto the valve body.

[0013] The invention additionally encompasses a method of preparing a
medication agent for administration to an individual. A syringe is
provided having a syringe barrel and a piston disposed at an initial
position relative to the syringe barrel. The piston has a piston sleeve
and a sleeve insert. A first component is provided within the syringe
barrel and a second component is provided within a vial. A valve is
associated with the fluid passageway between the vial and the barrel of
the syringe. The valve is initially in a closed position blocking fluid
passage through the passageway. The method includes repositioning the
valve and sliding the piston to join the first and second components. The
first and second components are mixed to form a medication agent and the
agent is drawn into the syringe barrel.

[0014] In a further aspect the invention includes a method of preparing a
composition including providing a syringe barrel having a barrel chamber
containing a first component and providing a piston having a compartment
containing a second component. The piston includes a piston sleeve and a
sleeve insert. The sleeve insert includes a tip and a body with a seal
that is over-molded onto the tip and an end of the piston sleeve. The
seal has at least one opening passing therethrough. The method includes
rotating the piston sleeve relative to the sleeve insert to establish
fluid communication between the compartment and the barrel chamber. The
piston is slid to join the first and second components and the first and
second components are mixed to form a composition. The composition is
drawn into the syringe chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Preferred embodiments of the invention are described below with
reference to the following accompanying drawings.

[0016] FIG. 1 is a side view and partial cross-sectional view of a mixing
assembly in accordance with one aspect of the invention.

[0017] FIG. 2 is a side view and partial cross-sectional view of a portion
of a syringe device in accordance with one aspect of the invention.

[0018] FIG. 3A is a side view of a portion of a syringe device with a
slidable housing disposed in a first position.

[0019] FIG. 3B is a side view of the portion of the syringe device of FIG.
3A shown with the slidable housing disposed in a second position.

[0020] FIG. 4A is a side view of a mixing assembly in accordance with one
aspect of the invention.

[0021] FIG. 4B is an exploded view of the assembly shown in FIG. 4A.

[0022] FIG. 5A is an exploded side view of a syringe piston in accordance
with one aspect of the invention.

[0024] FIG. 5C is a side view of an assembled portion of the syringe
piston shown in FIG. 5A.

[0025] FIG. 6 is a side view of a syringe piston in accordance with one
aspect of the invention having a tip portion connectable to alternative
stem portions.

[0026] FIG. 7 is an exploded side view of another syringe piston
configuration in accordance with one aspect of the invention.

[0027] FIG. 8 is a side view of a piercing device in accordance with one
aspect of the invention.

[0028] FIG. 9 is a side view of the FIG. 7 piston device in an assembled
configuration.

[0029] FIG. 10 is an exploded side view of an alternative mixing assembly
in accordance with another aspect of the invention.

[0030] FIG. 11A is an exploded side view of a portion of the system shown
in FIG. 10.

[0031] FIG. 11B is an enlarged cross-sectional view of a portion of the
assembled form of the system depicted in FIG. 10.

[0032] FIG. 12 is a side view of the assembled device shown in FIG. 10
having alternative features.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] This disclosure of the invention is submitted in furtherance of the
constitutional purposes of the U.S. Patent Laws "to promote the progress
of science and useful arts" (Article 1, Section 8).

[0034] In general the invention provides methodology and devices for
combining and mixing components to produce a mixture and encompasses
device configurations to allow such combining and mixing to occur without
contamination or exposing of the components or mixed agents to a
non-sterile environment. In particular, methodology of the invention
involves combining and mixing components to produce an administration
ready agent such as a medicant and in particular aspects includes
administering such agent to an individual. Accordingly, device
configurations of the invention allow combination of separate components
such that the combined and mixed components are administration-ready. The
general concepts and example devices in accordance with the invention are
illustrated in the accompanying FIGS. 1-12.

[0035] The device components and methods described and exemplified herein
can be utilized in conjunction with, or alternative configurations of,
the devices and methods described in U.S. patent application Ser. No.
11/238,880 which was filed Sep. 28, 2005 (henceforth the earlier filed
application). Accordingly, the specification and figures from such
earlier filed application are hereby incorporated by reference. It is to
be understood that many of the concepts of the present invention can be
utilized in conjunction with or can be adapted to other device
configurations including conventional syringe devices and components,
those described in the earlier application and those yet to be developed.

[0036] Where devices in accordance with the invention are used for
preparation of a medicant, the devices are preferably closed-system
mixing assemblies. An example of a mixing assembly 10 in accordance with
the invention is illustrated in FIG. 1. Mixing assembly 10 can comprise a
syringe body (or barrel) 100 and a piston 200 that has a fluid passageway
longitudinally through a portion of its length (discussed further below).
In some instances a reversibly attached cap (not shown) may be present
providing a fluid seal at a forward end of the syringe body.

[0037] Piston 200 has a first end 202 and an opposing second end 204
defining an overall length of the piston. A valve 300 is associated with
the fluid channel which passes through a portion of the length of the
piston. A vial port 206 is disposed along a segment of the length of the
piston stem and is configured to receive a vial 500 lengthwise within the
vial port. Preferably the fluid passageway through the piston extends
from the vial port through first end 202.

[0038] Piston 200 further includes a seal 208 which is able to form a
slidable fluid tight seal between the internal walls of the syringe body
and the sidewalls of the piston seal. Valve 300 can be configured to
selectively control fluid communication between the syringe chamber and
vial 500.

[0039] Referring to FIG. 2, such illustrates a fluid passageway 220
extending from first end 202 through seal 208 and lengthwise through the
piston to vial port 206. A piercing device 400 can be associated with
fluid channel 220 and can extend into port 206. An example piercing
device can be as described in the earlier filed application. Piercing
device 400 can have a fluid channel passing therethrough and can be
configured to puncture the vial septum and be retained across the septum
establishing fluid communication between the interior of the vial and
fluid passageway 220.

[0040] Vial port 206 can be formed by removal of all or a portion of one
or more piston fins 210. Preferably enough fin structure is retained to
allow vial retention and stabilization within port 206.

[0041] Valve 300 can be, for example, a two-way valve as illustrated or
can be an alternative valve type as described in the earlier filed
application.

[0042] For the syringe assembly shown in FIGS. 1 and 2, the device is
preferably initially provided in a configuration in which the vial is
sealed and disposed in a non-contact position relative to piercing
structure 400. In preparation for use the vial can be repositioned to
contact piercing device 400 and slid within the port allowing device 400
to puncture and cross the septum. Valve 300 can then be repositioned to
an `on` position establishing fluid communication between the vial and
the syringe chamber. Sliding of the piston relative to the syringe can be
utilized to combine syringe contents with vial contents. The two
components can be mixed by repeated sliding of the piston or by agitation
of the device. The mixed components can then be drawn into the syringe
and the valve closed in preparation for administration of the prepared
agent.

[0043] Referring to FIG. 3A, an alternative intra-piston vial port
configuration is illustrated. Features of the illustrated device in
common with the earlier described piston are numbered identically.
Features that are additional or different relative to the earlier device
are denoted by a letter appendage or with a unique numeric identifier.

[0044] The illustrated piston 200 has an internal passageway extending
from first end 202 to an intra-piston vial port 206a. The intra-stem vial
port is configured to receive a vial housing 510 which can house a vial
(not shown). Such vial housing can be insertable through an opening in
second end 204 of the piston. Referring to FIG. 3B, a plurality of
receiving slots 211 can be configured to guide and position housing 510
within the vial port. Piston 200 can comprise a piercing structure (not
shown) associated with the vial port and the fluid passageway. Piston 200
can preferably be initially provided such that housing 510 and a vial
received internally within the housing are disposed in a non-contact
position such that the piercing device does not contact or penetrate the
vial lid or septum. During preparation for use the vial housing and
internal vial can be slid toward first end 202 to allow penetration of
the vial septum or cap by the piercing device thereby establishing fluid
communication between the interior of the vial and the fluid passageway
of the piston. Fluid passage through the passageway can be selectively
controlled by valve 300. Preparation of a medication agent for
administration to an individual can be performed by providing an
associated syringe (not shown), and utilizing methodology analogous to
that described above for the device depicted in FIG. 1.

[0045] Another alternative configuration of the invention is described
with reference to FIGS. 4A-4B. Referring initially to FIG. 4A, a piston
200 is illustrated insertable within a syringe 100 having an internal
chamber 102. Syringe piston 200 has an internal passageway passing
longitudinally such that the passageway traverses the length of the
piston. Fluid passage through the passageway is selectively controlled by
valve 300 associated with such passageway.

[0046] As illustrated, a first end 202 (see FIG. 4B) is inserted within
the syringe barrel and a vial housing 600 is associated with second end
204 of the piston. Vial housing 600 can comprise, for example, two parts
602 and 604. First part 602 can, in particular instances, be an extension
of piston 200. Housing part 602 can be integral with, permanently
attached to or reversibly attached to piston 200. A second portion 604 of
the vial housing can be configured to be joinable to first portion 602
such that a vial inserted within the container can be completely enclosed
within the housing. Such enclosure of a medicant vial can prevent vial
breakage and can advantageously avoid removal and improper replacement of
the vial and/or inadvertent substitution of the vial with another vial
possibly containing an improper diluent or other agent.

[0047] Joining of the second part 604 of the housing to the first part of
the housing can comprise, for example, inserting a portion of part 604
into the first part, inserting a portion of part 602 within part 604,
threading of one of the two parts into the other of the two parts, and/or
use of other appropriate fittings or joining techniques. In particular
embodiments, part 604 can preferably be configured to be stabilized in a
first position and can be further extended within the second part to a
second position upon application of force (sliding, twisting or other
force based upon the design of the particular fitting configuration
utilized). Such configuration can allow an enclosed vial to be moved from
a first "non-contact" position relative to a piercing device (see FIG.
4B) into a second "access" position where the piercing device is able to
pierce a vial septum or other vial cover and thereby provide access to
vial contents.

[0048] In particular implementations the vial housing portion can have an
adaptor appendage 606 configured to adapt the syringe device for use in
conjunction with a syringe pump. Such appendage can preferably include a
stem 608 protruding from part 604, where the stem has a first diameter.
Stem portion 608 extends to a disk structure 610 where the disk structure
has a diameter greater than the stem structure and is configured for
insertion into a slot in a piston driver of a syringe pump. Such
configuration can allow devices in accordance with the invention to be
utilized in a conventional syringe pump. The presence of the insertable
disk, when inserted into a slot of the piston driver of the syringe pump,
can prevent inadvertent advancement of the plunger when the pump is off.
Devices of the invention can alternatively be manually manipulated.

[0049] Referring to FIG. 4B, such shows an exploded view of the device
depicted in FIG. 4A. These figures illustrate the association of piercing
device 400 which can be at second end 204 of piston 200 and can extend
into first part 602 of the vial housing. FIG. 4B additionally illustrates
an alternative placement of valve 300 with respect to the overall length
of piston 200. It is to be understood that the placement of valve 300
along the length of the piston is not limited to any particular location
and that the depicted locations are for purposes of illustration only.

[0050] As further illustrated in FIG. 4B a seal 208 can be mounted on
first end 202 of syringe piston 200. Seal 208 preferably has an outer
diameter along at least a portion of its length that forms a fluid seal
between the chamber walls and the seal. Where piston 200 comprises an
internal fluid passageway, seal 208 can preferably have one or more
openings to allow fluid communication between the internal passageway of
the piston and the syringe chamber.

[0051] The mixing/administration system 10 depicted in FIGS. 4A-4B can
initially be provided in a "non-contact" position where piercing
structure 400 does not puncture the cap or septum of vial 500. In a
particular configuration, positioning of container parts 602 and 604 with
respect to one another can be stabilized utilizing a plastic shrink-wrap
at least at the junction of the two housing parts. The shrink-wrap can
provide a sterile retainer and prevent inadvertent or unintentional
engagement of the piercing device with the vial septum. Positioning can
also or alternatively utilize a tack weld or molded attachment
stabilization where a breakable attachment is provided that can be broken
by application of force (twisting, sliding or other force depending upon
the particular containment configuration and positioning of the breakable
attachment(s)). The two-part container portion of the described syringe
device configuration can be formed utilizing materials such as plastic
materials, preferably hard plastic materials. Spot welding or tacking can
be achieved utilizing, for example, RF welding, microwave welding, heat
welding or other appropriate plastic welding.

[0052] Another aspect of the invention is described with reference to
FIGS. 5A-5C. In general, this aspect of the invention involves
over-molding of elastomeric seal portions onto hard plastic body pieces
of various parts of devices in accordance with the invention.
Over-molding involves molding of an overlying part directly onto an
underlying supporting part. It is to be understood that over-molding can
be utilized with alternative piston and valve bodies in addition to those
specifically described in this particular aspect of the invention.
Alternative piston and valve bodies can include, for example, alternative
pistons and valves described herein, pistons and valves described in the
earlier filed application, conventional pistons and valves and piston,
and valve configurations yet to be developed.

[0053] Referring initially to FIG. 5A, a piston 200 is illustrated having
a valve 300 configured to fit into an opening 250, and having a channel
220 extending longitudinally through the piston. A piston seal 208a is
illustrated having an opening 219 which extends through the seal.
Although FIG. 5A illustrates piston 200 in an exploded view, it is to be
understood that seal 208a is permanently attached to the piston during
the over-molding process.

[0054] Piston 200 preferably has at least one projection 223 disposed at
or near first end 202 of the piston. The projection or projections can
advantageously support the over-molded seal and can assist in retaining
the seal on the first end of the piston. Where the piston is configured
to have a fluid passageway or channel passing longitudinally
therethrough, the over-molding process can preferably provide the
over-molded seal to have one or more openings extending through the seal
to provide fluid communication between the passage through the piston and
the internal region of an associated syringe body.

[0055] The over-molding process utilized can be adapted for various
syringe body designs such that the over-molded seal has a forward end
which is shaped to conform to the taper/shape of the interior of the
syringe body at the forward end of the syringe body. The seal can
preferably be molded to provide a seal diameter to allow insertion and
movement of the seal within the syringe chamber while providing a fluid
seal along the chamber sidewalls. In particular aspects, the
diameter/size of the seal mold can be modified to produce seals that fit
varying syringe barrel sizes without varying the piston size/diameter.

[0056] In a similar aspect, valve 300 can comprise a valve body 302 and an
over-molded valve cap 310. Valve body 302 can preferably have one or more
projections 304, 306 configured to support and retain the over-molded cap
310.

[0057] Valve 300 can be, for example, a push-pull type valve as
illustrated in FIG. 5A. In the configuration shown, the push-pull valve
body has a larger projection 306 at the inserted end of the valve. The
presence of the large projection can provide a shape configuration to
assist in positioning and/or retaining the valve within the port when
pulling the valve into an open position. It is to be understood that the
invention contemplates utilization of alternative valve types such as,
for example, a rotatable valve having an opening passing through the body
and the over-molded seal.

[0058] Valve cap 310 and seal 208a can comprise, for example, elastomeric
materials. The elastomeric materials utilized can be the same or can
differ from one another. Similarly, piston 200 and valve body 302 can be
formed of hard plastic materials and can be the same or can differ
relative to one another. Examples of elastomeric materials that can be
utilized include, but are not limited to, polyurethanes,
polypropylene-EPDM, other polypropylenes, polysiloxane and/or silicone
materials, butyl materials, isoprenes, neoprenes, polyethylenes and
various copolymers, composites, blends or other combinations of such
materials. Examples of plastics that can be utilized for piston and/or
valve body formation include, but are not limited to, polyethylenes,
polypropylenes, polycycloolefines, polyvinyl chlorides (PVC), polyamides
(including aliphatic and aromatic variants), polyesters, polycarbonates,
polyacrylates, polyurethanes, copolymers, blends, composites and
combinations thereof.

[0060] Where over-molding is utilized to form pistons and/or valves in
accordance with the invention, the stem/body portions can be fabricated
in a first process and the over-molded seal/cap portion can be formed in
a second process. The over-molding will form the seal/cap directly onto
the body or stem portion. The over-molding can occur directly after
formation of the underlying part or the underlying part can be formed
initially and can be removed from the corresponding mold, transferred
and/or stored prior to the over-molding process.

[0061] The over-molding process can advantageously avoid manual assembly
of the piston or body with respect to the cap or stopper. Additional
advantages of providing an over-molded elastomeric seal include
minimization or prevention of fluid leakage between the seal and the
underlying piston, and a secure attachment such that the seal does not
pull away from the underlying piston during piston rotation relative to
the syringe or drawing of the piston within the syringe. Additionally,
the seal can be configured to have a thin wall across the first end of
the piston. Relative to conventional piston seals, the thin wall of the
over-molded seal can decrease the piston rebound and thereby minimize the
reflux of fluid back through the tip of the syringe. Further, the seal
can be molded to have a central protrusion on the front face (not shown)
configured to insert at least partially into the fluid passage through
the syringe tip to further minimize fluid retained in the syringe. This
feature can be especially advantageous for administration of costly
medical agents.

[0062] Referring to FIG. 6, over-molding can also be utilized in
conjunction with a multipart piston configuration. In this aspect a
piston seal 208 can be over-molded onto a piston tip 203 which can be
threaded or otherwise attached to alternative piston stems 205, 205'.
Stems 205 and 205' and tip 203 can have internal fluid passageways or can
alternatively be solid core pieces. Tip 203 can be joined to a piston
stem 205 or 205' by insertion of an attachment portion of the tip into an
opening 209 of the stem 205 or 205'. In particular configurations the
joining can utilize threading, snap-locking, press-fitting, application
of an appropriate adhesive or other appropriate joining techniques.

[0063] The over-molded seal 208 can be molded to have a diameter `d.sub.1`
which can vary depending upon the diameter of the syringe body (not
shown) that will be utilized. The tip along with the over-molded seal can
be joined with a piston of an appropriate diameter (e.g. d2 or
d3) for use with the particular syringe barrel. Accordingly, a
single tip configuration can be utilized for a wide range of seal,
syringe barrel and piston sizes.

[0064] Another embodiment of the invention is described with reference to
FIGS. 7-9. Referring initially to FIG. 7, piston 200 can include a piston
sleeve 240 and a sleeve insert 230 configured to insert within sleeve
240. Sleeve portion 240 can have a seal 208 mounted on first end 202. The
seal can have an opening 219a which passes through the side of the seal
and aligns with a similar opening which passes through sleeve portion
240. Sleeve 240 can additionally have a base ring 242 or other base
structure to allow manipulation of the sleeve.

[0065] Sleeve insert 230 can comprise a channel 232 passing from a first
end 243 of the piston insert along an outside surface of the insert and
through a collar 234 at opposing end 247 of the insert. A piercing
structure 400 can be provided in association with second end 247 of the
piston insert. Referring to FIG. 8, such shows the detail configuration
of an example of a piercing device configuration that can be utilized in
association with the piston illustrated in FIG. 7.

[0066] The piercing structure 400 depicts an illustrative piercing
structure in accordance with the invention. Piercing structure 400 can be
described as having a head segment 401 comprising a tip 402 disposed at a
first end. Piercing structure 400 additionally has a stem/body portion
403 which extends from head portion 401 to a base surface 404 disposed at
a second end of the structure opposing the first end. A channel 406 or
alternative fluid passageway extends through the base surface and
preferably through an entirety of body portion 403.

[0067] Piercing structure 400 can preferably comprise an opening 402a
which aligns with channel 232 of insert 200 upon seating of the piercing
structure in association with piston 200.

[0068] The piercing structure shown in FIG. 8 is an illustrative shape and
form. In a preferred aspect of the invention channel 406 extends less
than an entirety of an internal length of head segment 401 such that the
channel does not pass through tip 402. Rather, one or more access holes
408 are provided, for example, through one or both of the external
surfaces of the head portion. Configurations of the piercing structure
where the channel does not pass through the tip can advantageously
minimize or prevent coring of a septum material or plugging of the
channel during a piercing operation. Additional aspects pertaining to
piercing structures are set forth in the earlier filed application.

[0069] Referring next to FIG. 9, such illustrates the piston device shown
in FIG. 7 in an assembled configuration. Sleeve insert 230 is inserted
within sleeve portion 240. Insert 230 can be rotated relative to sleeve
portion 240 to allow the two parts of the device to function as a
rotatable valve. Typically, first end 202 of the assembled structure will
be inserted within a syringe barrel (not shown). The device can initially
be provided with an accompanying vial such that the vial septum is
intact. In preparation for administration of a medicinal agent, piercing
structure 400 can be utilized to pierce the vial septum. Rotation of
insert 230 relative to sleeve 240 can be utilized to align the fluid
channel of the insert with opening 219a through the piston seal and the
corresponding opening through the piston sleeve. Such alignment can
establish fluid communication between the syringe chamber and the vial.
Subsequent combining and mixing of medication components can be performed
as described above. Upon completion of the mixing, the valve can be
closed by rotation of the insert 230 relative to the sleeve. The
administration-ready composition can then be administered or can be
stored prior to administration.

[0070] Another mixing and administration system 10 having a multipart
piston is depicted in FIGS. 10-12. Referring initially to FIG. 10, system
10 can include a syringe barrel 10 having an internal chamber 102. System
10 additionally includes a piston 200 inclusive of a piston sleeve 240
and a sleeve insert 230. Insert 230 can be described as having a stem
portion 233, at least a portion of which is hollow to serve as a
container 255. An insert cap portion 231 can be configured to attach to
piston stem 233 thereby covering and enclosing container 255. An
appendage 237 can extend from the piston insert. Appendage 237 can
comprise a stem portion 235 and a disk portion 239 where disk portion 239
is configured to fit into a slot on a piston driver of a syringe pump.

[0071] Sleeve portion 240 can include a piston seal 208. Seal 208 can
preferably be over-molded and can comprise a shape having tapered walls
213 that match the internal taper region 103 of syringe chamber 102.

[0072] Referring to FIG. 11A, cap portion 231 can be configured to provide
valve action utilizing an inserted compression spring 257 and an
overlying retainer 258. Cap 231 and retainer 258 can be formed of hard
plastic materials such as those described above. Spring 258 can be formed
of an elastomeric material such as those elastomeric materials set forth
above.

[0073] Referring next to FIG. 11B, in the illustrated embodiment
over-molded seal 208 can be over-molded onto piston sleeve 240 and also
onto cap 231. The internal valve spring and the retainer are provided
prior to the over-molding process. Once the over-molding process is
complete, stem portion 233 can be positioned by insertion of the stem
within sleeve portion 240. The internal container of insert 233 will
typically contain a component of a medicinal agent such as, for example,
a lyophilized powder, at the time of insertion into the sleeve. Cap 231
and stem portion 233 can preferably be configured to include a snap
fitting, press fitting or other appropriate joining configuration such
that, once joined, the cap and stem portions do not pull apart upon
drawing back of the piston.

[0074] FIG. 12 shows an assembled device analogous to the device shown in
FIG. 10 and having additional optional features. As illustrated, piston
200 comprising sleeve 240 and insert 230 is inserted within a syringe
barrel 100. Sleeve 240 can comprise extension tabs 262 and insert 230 can
also comprise extension tabs 260. The extension tabs present on the
sleeve and the insert can assist in manipulation of the valve associated
with the piston. Squeezing together of the tabs in the A direction can
open the valve. Rotation of the insert relative to the sleeve (direction
B) can then be performed to position the tabs to "lock" the sleeve and
insert position relative to one another thereby locking the valve into
the open position. To close the valve the insert can be rotated in an
opposing direction and tabs 260 can be moved apart relative to tabs 262.

[0075] Preparation of an administration ready agent utilizing the device
depicted in FIG. 12 can be performed in a manner analogous to that
described above with the exception that the internal container within
insert 230 replaces the earlier described vial. The mixing/administration
system 10 shown in FIG. 12 can additionally include an appendage
associated with the piston and opposing syringe 100 where such appendage
is configured to allow insertion into a slot of a piston driver of a
syringe pump.

[0076] Packaging of the devices of the embodiments described herein can
utilize conventional packaging techniques, or can utilize the packaging
techniques described in the earlier filed application, adapted for the
specific device being packaged.

[0077] The features and embodiments described herein can be combined with
one another where appropriate, and can be utilized in conjunction with
features and embodiments disclosed in the earlier filed application. The
features and embodiments of the invention are suitable or adaptable for
use in combination with conventional syringe components, vials, and
devices, as well as those yet to be developed.

[0078] In compliance with the statute, the invention has been described in
language more or less specific as to structural and methodical features.
It is to be understood, however, that the invention is not limited to the
specific features shown and described, since the means herein disclosed
comprise preferred forms of putting the invention into effect. The
invention is, therefore, claimed in any of its forms or modifications
within the proper scope of the appended claims appropriately interpreted
in accordance with the doctrine of equivalents.